Drug-induced Adverse Events

Sex-Related Differences in the Pharmacological Treatment of Major Depression - Are Women and Men Treated Differently?
Psychiatr Danub. 2022 Summer;34(2):219-228. doi: 10.24869/psyd.2022.219.
ABSTRACT
BACKGROUND: In the last decade, sex-related medicine has become an increasingly important area of research as insights in this field can improve treatment strategies and recovery. The aim of this study was to investigate sex-related differences in the prescription and kinds of psychopharmacological treatment in individuals with unipolar affective disorder.
SUBJECTS AND METHODS: Data collected on 388 patients attending a psychiatric rehabilitation clinic (194 females, 194 males, mean age 52.3 years, standard deviation 7.8 years), who were matched by age and severity of depression, were analyzed. Depression severity and information on drug type and quantity were assessed at the beginning of the rehabilitation program and compared between women and men.
RESULTS: A significant difference between females and males was found in the frequency of prescribing bupropion (females: 3.61%, males: 12.89%; p=0.001) and mirtazapine (females: 5.15%, males: 13.40%; p=0.005). In terms of polypharmacy, the results showed that over 53% of the patients were taking two or more psychotropic substances as a long-term therapy and that 34% of them were taking three to five different substances. No sex-related differences were found concerning the number of psychotropic drugs taken by the patients.
CONCLUSION: The higher frequency of prescriptions for bupropion and mirtazapine in men might be explained by the adverse drug reactions of the drugs (e.g., fewer sexually adverse drug reactions, weight gain) and a known interaction with oral contraception. It remains unclear whether these aspects are taken into consideration for each patient in terms of their special needs and conditions or whether it is a decision based on the patient's sex. Given a similar severity of depression, men and women are prescribed a similar number of psychotropic substances. However, the high number of psychotropic drugs prescribed on average should be noted. Well-trained healthcare professionals should focus on regularly assessing and optimizing treatment regimens.
PMID:35772131 | DOI:10.24869/psyd.2022.219
Triptolide Induces Liver Injury by Regulating Macrophage Recruitment and Polarization via the Nrf2 Signaling Pathway
Oxid Med Cell Longev. 2022 Jun 20;2022:1492239. doi: 10.1155/2022/1492239. eCollection 2022.
ABSTRACT
Triptolide (TP) has limited usage in clinical practice due to its side effects and toxicity, especially liver injury. Hepatic macrophages, key player of liver innate immunity, were found to be recruited and activated by TP in our previous study. The nuclear factor-erythroid-2-related factor 2 (Nrf2) pathway exerts a protective role in TP-induced liver damage, but its effect on the functions of hepatic macrophage has not been elucidated. Here, we determined whether TP can regulate the recruitment and polarization of hepatic macrophages by inhibiting Nrf2 signaling cascade. Our results demonstrated that TP inhibited the Nrf2 signaling pathway in hepatic macrophages. The changes in hepatic macrophages were responsible for the increased susceptibility toward inflammatory stimuli, and hence, TP pretreatment could induce severe liver damage upon the stimulation of a nontoxic dose of lipopolysaccharides. In addition, the Nrf2 agonist protected macrophages from TP-induced toxicity and Nrf2 deficiency significantly aggravated liver injury by enhancing the recruitment and M1 polarization of hepatic macrophages. This study suggests that Nrf2 pathway-mediated hepatic macrophage polarization plays an essential role in TP-induced liver damage, which can serve as a potential therapeutic target for preventing hepatotoxicity induced by TP.
PMID:35770044 | PMC:PMC9236772 | DOI:10.1155/2022/1492239
Safety update: monitoring patients taking amiodarone
Drug Ther Bull. 2022 Jun 30:dtb-2022-000034. doi: 10.1136/dtb.2022.000034. Online ahead of print.
ABSTRACT
Overview of: Medicines and Healthcare products Regulatory Agency. Amiodarone (Cordarone X): reminder of risks of treatment and need for patient monitoring and supervision. Drug Safety Update 2022;15:5-7.
PMID:35772937 | DOI:10.1136/dtb.2022.000034
Apolipoprotein B, Residual Cardiovascular Risk After Acute Coronary Syndrome, and Effects of Alirocumab
Circulation. 2022 Jun 30:101161CIRCULATIONAHA121057807. doi: 10.1161/CIRCULATIONAHA.121.057807. Online ahead of print.
ABSTRACT
BACKGROUND: Apolipoprotein B (apoB) provides an integrated measure of atherogenic risk. Whether apoB levels and apoB lowering hold incremental predictive information on residual risk after acute coronary syndrome beyond that provided by low-density lipoprotein cholesterol is uncertain.
METHODS: The ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) compared the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab with placebo in 18 924 patients with recent acute coronary syndrome and elevated atherogenic lipoproteins despite optimized statin therapy. Primary outcome was major adverse cardiovascular events (MACEs; coronary heart disease death, nonfatal myocardial infarction, fatal/nonfatal ischemic stroke, hospitalization for unstable angina). Associations between baseline apoB or apoB at 4 months and MACEs were assessed in adjusted Cox proportional hazards and propensity score-matched models.
RESULTS: Median follow-up was 2.8 years. In proportional hazards analysis in the placebo group, MACE incidence increased across increasing baseline apoB strata (3.2 [95% CI, 2.9-3.6], 4.0 [95% CI, 3.6-4.5], and 5.5 [95% CI, 5.0-6.1] events per 100 patient-years in strata <75, 75-<90, ≥90 mg/dL, respectively; Ptrend<0.0001) and after adjustment for low-density lipoprotein cholesterol (Ptrend=0.035). Higher baseline apoB stratum was associated with greater relative (Ptrend<0.0001) and absolute reduction in MACEs with alirocumab versus placebo. In the alirocumab group, the incidence of MACEs after month 4 decreased monotonically across decreasing achieved apoB strata (4.26 [95% CI, 3.78-4.79], 3.09 [95% CI, 2.69-3.54], and 2.41 [95% CI, 2.11-2.76] events per 100 patient-years in strata ≥50, >35-<50, and ≤35 mg/dL, respectively). Compared with propensity score-matched patients from the placebo group, treatment hazard ratios for alirocumab also decreased monotonically across achieved apoB strata. Achieved apoB was predictive of MACEs after adjustment for achieved low-density lipoprotein cholesterol or non-high-density lipoprotein cholesterol but not vice versa.
CONCLUSIONS: In patients with recent acute coronary syndrome and elevated atherogenic lipoproteins, MACEs increased across baseline apoB strata. Alirocumab reduced MACEs across all strata of baseline apoB, with larger absolute reductions in patients with higher baseline levels. Lower achieved apoB was associated with lower risk of MACEs, even after accounting for achieved low-density lipoprotein cholesterol or non-high-density lipoprotein cholesterol, indicating that apoB provides incremental information. Achievement of an apoB level ≤35 mg/dL may reduce lipoprotein-attributable residual risk after acute coronary syndrome.
REGISTRATION: URL: https://www.
CLINICALTRIALS: gov. Unique identifier: NCT01663402.
PMID:35770629 | DOI:10.1161/CIRCULATIONAHA.121.057807
Pharmacokinetics, safety, and tolerability of gepotidacin administered as single or repeat ascending doses, in healthy adults and elderly subjects
Clin Transl Sci. 2022 Jun 29. doi: 10.1111/cts.13359. Online ahead of print.
ABSTRACT
Gepotidacin, a novel, first-in-class triazaacenaphthylene antibiotic, inhibits bacterial DNA replication by a distinct mechanism of action. We report the pharmacokinetics, safety, and tolerability of gepotidacin following single or multiple ascending doses. Studies 1 and 2 were randomized, single-blind, placebo-controlled trials in healthy adults aged 18-60 years, who received single (Study 1 [NCT02202187]; 100-3000 mg) or repeat (Study 2 [NCT01706315]; 400 mg twice daily to 2000 mg thrice daily) ascending doses of gepotidacin. Study 3 (NCT02045849) was an open-label, 3-part, study in healthy adults; here we report on part 3, a 2-period, repeat-dose, crossover study. Healthy elderly participants received repeat 1500 mg gepotidacin twice daily with or without a moderate-fat meal. Primary endpoints were pharmacokinetics (Studies 1 and 2) and safety (Studies 1 and 3 part 3). Gepotidacin pharmacokinetic parameters were comparable across all ages and were dose proportional. In all studies, gepotidacin was readily absorbed with median time to maximum concentration observed (tmax ) ranging from 1.0-4.0 h across all doses. Median apparent terminal phase half-life (t½ ) was consistent across studies and doses (range: 5.97-19.2 h). Steady state was achieved following repeated dosing for 3-5 days; gepotidacin pharmacokinetic parameters were time invariant after repeated oral dosing. A moderate-fat meal did not affect gepotidacin pharmacokinetic parameters. Gepotidacin was generally well tolerated, with no drug-related serious adverse events reported. Collectively, these pharmacokinetic and safety data across a wide range of doses in healthy participants aged ≥ 18 years support the development of gepotidacin in further clinical studies.
PMID:35769034 | DOI:10.1111/cts.13359
Analysis of adverse drug events in pulmonary Mycobacterium avium complex disease using spontaneous reporting system
BMC Infect Dis. 2022 Jun 29;22(1):580. doi: 10.1186/s12879-022-07568-z.
ABSTRACT
BACKGROUND: In Japan, Mycobacterium avium complex lung disease (MAC-LD) is the most common in nontuberculous mycobacterial lung disease. Patients often experience adverse events, resulting in the discontinuation of treatment, which causes treatment failure. The JADER (Japanese Adverse Drug Event Report) database is a database of adverse events that allows us to collect real-world data on adverse events. We can collect large-scale data cost-effectively and detect signals of potential adverse events such as reporting odds ratio (ROR) by using spontaneous reporting systems. In this study, we aimed to elucidate the adverse events of clarithromycin (CAM), ethambutol (EB), and rifampicin (RFP) using the JADER database.
METHODS: We included cases of MAC-LD between April 2004 and June 2017. We investigated sex, age, and medications that may have caused the adverse events, outcomes, and time of onset. We calculated the safety signal index as the ROR. Time-to-event analysis was performed using the Weibull distribution.
RESULTS: The total number of adverse events of CAM, EB, and RFP was 2780, with 806 patients. In the overall adverse events, hematologic and lymphatic disorders were the most common adverse events, with 17.3%, followed by eye disorders (16.6%), and hepatobiliary disorders (14.0%). The outcomes were as follows: recovery, 40.0%; remission, 27.1%; non-recovery, 11.2%; and death, 7.1%. Regarding the most common onset time of CAM, EB, and RFP was within 120 days at 40%, 181-300 days at 43.6%, and within 120 days at 88.5%. For CAM, the RORs of infections and infestations, hepatobiliary system disorders, and immune system disorders were 4.13 (95% confidence interval [CI], 2.3-7.44), 2.61 (95% CI, 1.39-4.91), and 2.38 (95% CI, 1.04-5.44). For EB, the ROR of eye disorders was 215.79 (95% CI, 132.62-351.12). For RFP, the RORs of renal and urinary tract disorders and investigations were 7.03 (95% CI, 3.35-14.77) and 6.99 (95% CI, 3.22-15.18). The β value of EB was 2.07 (95% CI, 1.48-2.76), which was classified as a wear-out failure type.
CONCLUSIONS: For MAC-LD, the adverse event which has the highest ROR is infections and infestations in CAM, eye disorders in EB, renal and urinary tract disorders in RFP. Adverse events of EB occur after 180 days, whereas the adverse events of CAM and RFP occur early in the course of treatment.
PMID:35768763 | DOI:10.1186/s12879-022-07568-z
Knowledge, attitudes and practices of pharmacovigilance in the context of COVID-19 in health professionals of the peruvian social insurance
Rev Peru Med Exp Salud Publica. 2022 Jan-Mar;39(1):91-97. doi: 10.17843/rpmesp.2022.391.10651. Epub 2022 Jun 24.
ABSTRACT
The study aimed to evaluate a group of health professionals' knowledge, attitudes, and practices on pharmacovigilance in the context of COVID-19 in the Peruvian Social Health Insurance (EsSalud). A descriptive secondary analysis was carried out on a database that included responses from an online survey conducted by the Institutional Referral Center for Pharmacovigilance and Technovigilance of EsSalud. Of 144 participants, 66% showed a high level of knowledge and 81.2% had a positive attitude; however, 71.5% had an inadequate level of pharmacovigilance practice. Although EsSalud professionals demonstrated a high level of knowledge and positive attitude to implement pharmacovigilance, this is not reflected in the practice of this activity during the SARS-CoV-2 pandemic. Strategies should be implemented to integrate pharmacovigilance into healthcare activities to benefit patient safety.
PMID:35766746 | DOI:10.17843/rpmesp.2022.391.10651
Liver and kidney toxicity caused by wild mushroom poisoning
Hong Kong Med J. 2022 Jun;28(3):271.e1-271.e2. doi: 10.12809/hkmj208892.
NO ABSTRACT
PMID:35765737 | DOI:10.12809/hkmj208892
An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period
Indian J Med Ethics. 2022 Apr-Jun;VII(2):108-113. doi: 10.20529/IJME.2021.094.
ABSTRACT
The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year period and compare it with two similar earlier audits. WLs were reviewed and classified as per stakeholders and further categorised as per predefined violation themes. The chi-square test was performed for trend analysis of WLs. A total of 62 WLs were issued to the three stakeholders. The maximum number of WLs were issued to the clinical investigators (36/62, 58.06%), followed by sponsors (19/62, 30.64%), and least to the IRBs (7/62, 11.29%). Among sponsors, lack of standard operating procedures for the monitoring, receipt, evaluation and reporting of post-marketing adverse drug events was the most common violation theme (8/19, 42.1%). Among clinical investigators, deviation from investigational plan was the most common violation theme (31/36, 86.11%.). For IRBs, inadequate documentation was the most common violation theme (6/7, 85.71%). We saw an overall reduction in the number of WLs issued to the stakeholders. Thus, we identified multiple areas on which each stakeholder should work for improvement.
PMID:35765256 | DOI:10.20529/IJME.2021.094
Update on metformin safety in pregnancy
Drug Ther Bull. 2022 Jul;60(7):99. doi: 10.1136/dtb.2022.000032.
ABSTRACT
Overview of: Medicines and Healthcare products Regulatory Agency. Metformin in pregnancy: study shows no safety concerns. Drug Safety Update 2022;15:3.
PMID:35768138 | DOI:10.1136/dtb.2022.000032
Pharma payments to APPGs
Drug Ther Bull. 2022 Jul;60(7):100. doi: 10.1136/dtb.2022.000031.
ABSTRACT
Overview of: Rickard E, Ozieranski P. A hidden web of policy influence: The pharmaceutical industry's engagement with UK's All-Party Parliamentary Groups. PLoS One 2021;16:e0252551.
PMID:35768137 | DOI:10.1136/dtb.2022.000031
Phase I Clinical Trial of Prostate-Specific Membrane Antigen-Targeting <sup>68</sup>Ga-NGUL PET/CT in Healthy Volunteers and Patients with Prostate Cancer
Korean J Radiol. 2022 Jun 20. doi: 10.3348/kjr.2022.0176. Online ahead of print.
ABSTRACT
OBJECTIVE: 68Ga-NGUL is a novel prostate-specific membrane antigen (PSMA)-targeting tracer based on Glu-Urea-Lys derivatives conjugated to a 1,4,7-triazacyclononane-N, N', N″-triacetic acid (NOTA) chelator via a thiourea-type short linker. This phase I clinical trial of 68Ga-NGUL was conducted to evaluate the safety and radiation dosimetry of 68Ga-NGUL in healthy volunteers and the lesion detection rate of 68Ga-NGUL in patients with prostate cancer.
MATERIALS AND METHODS: We designed a prospective, open-label, single-arm clinical trial with two cohorts comprising six healthy adult men and six patients with metastatic prostate cancer. Safety and blood test-based toxicities were monitored throughout the study. PET/CT scans were acquired at multiple time points after administering 68Ga-NGUL (2 MBq/kg; 96-165 MBq). In healthy adults, absorbed organ doses and effective doses were calculated using the OLINDA/EXM software. In patients with prostate cancer, the rates of detecting suspicious lesions by 68Ga-NGUL PET/CT and conventional imaging (CT and bone scintigraphy) during the screening period, within one month after recruitment, were compared.
RESULTS: All 12 participants (six healthy adults aged 31-32 years and six prostate cancer patients aged 57-81 years) completed the clinical trial. No drug-related adverse events were observed. In the healthy adult group, 68Ga-NGUL was rapidly distributed, with the highest uptake in the kidneys. The median effective dose coefficient was calculated as 0.025 mSv/MBq, and cumulative activity in the bladder had the highest contribution. In patients with metastatic prostate cancer, 229 suspicious lesions were detected using either 68Ga-NGUL PET/CT or conventional imaging. Among them, 68Ga-NGUL PET/CT detected 199 (86.9%) lesions and CT or bone scintigraphy detected 114 (49.8%) lesions.
CONCLUSION: 68Ga-NGUL can be safely applied clinically and has shown a higher detection rate for the localization of metastatic lesions in prostate cancer than conventional imaging. Therefore, 68Ga-NGUL is a valuable option for prostate cancer imaging.
PMID:35762185 | DOI:10.3348/kjr.2022.0176
SPARSE: a sparse hypergraph neural network for learning multiple types of latent combinations to accurately predict drug-drug interactions
Bioinformatics. 2022 Jun 24;38(Supplement_1):i333-i341. doi: 10.1093/bioinformatics/btac250.
ABSTRACT
MOTIVATION: Predicting side effects of drug-drug interactions (DDIs) is an important task in pharmacology. The state-of-the-art methods for DDI prediction use hypergraph neural networks to learn latent representations of drugs and side effects to express high-order relationships among two interacting drugs and a side effect. The idea of these methods is that each side effect is caused by a unique combination of latent features of the corresponding interacting drugs. However, in reality, a side effect might have multiple, different mechanisms that cannot be represented by a single combination of latent features of drugs. Moreover, DDI data are sparse, suggesting that using a sparsity regularization would help to learn better latent representations to improve prediction performances.
RESULTS: We propose SPARSE, which encodes the DDI hypergraph and drug features to latent spaces to learn multiple types of combinations of latent features of drugs and side effects, controlling the model sparsity by a sparse prior. Our extensive experiments using both synthetic and three real-world DDI datasets showed the clear predictive performance advantage of SPARSE over cutting-edge competing methods. Also, latent feature analysis over unknown top predictions by SPARSE demonstrated the interpretability advantage contributed by the model sparsity.
AVAILABILITY AND IMPLEMENTATION: Code and data can be accessed at https://github.com/anhnda/SPARSE.
SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.
PMID:35758803 | DOI:10.1093/bioinformatics/btac250
Analyzing adverse drug reaction using statistical and machine learning methods: A systematic review
Medicine (Baltimore). 2022 Jun 24;101(25):e29387. doi: 10.1097/MD.0000000000029387.
ABSTRACT
BACKGROUND: Adverse drug reactions (ADRs) are unintended negative drug-induced responses. Determining the association between drugs and ADRs is crucial, and several methods have been proposed to demonstrate this association. This systematic review aimed to examine the analytical tools by considering original articles that utilized statistical and machine learning methods for detecting ADRs.
METHODS: A systematic literature review was conducted based on articles published between 2015 and 2020. The keywords used were statistical, machine learning, and deep learning methods for detecting ADR signals. The study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement (PRISMA) guidelines.
RESULTS: We reviewed 72 articles, of which 51 and 21 addressed statistical and machine learning methods, respectively. Electronic medical record (EMR) data were exclusively analyzed using the regression method. For FDA Adverse Event Reporting System (FAERS) data, components of the disproportionality method were preferable. DrugBank was the most used database for machine learning. Other methods accounted for the highest and supervised methods accounted for the second highest.
CONCLUSIONS: Using the 72 main articles, this review provides guidelines on which databases are frequently utilized and which analysis methods can be connected. For statistical analysis, >90% of the cases were analyzed by disproportionate or regression analysis with each spontaneous reporting system (SRS) data or electronic medical record (EMR) data; for machine learning research, however, there was a strong tendency to analyze various data combinations. Only half of the DrugBank database was occupied, and the k-nearest neighbor method accounted for the greatest proportion.
PMID:35758373 | DOI:10.1097/MD.0000000000029387
TOPIRAMATE-INDUCED BILATERAL ANGLE-CLOSURE GLAUCOMA. A CASE REPORT
Cesk Slov Oftalmol. 2022 Spring;78(3):138-142. doi: 10.31348/2022/16.
ABSTRACT
INTRODUCTION: Topamax (topiramate) is a drug used in the treatment of epilepsy or migraine. Its use may rarely be associated with the occurrence of secondary angle-closure glaucoma due to supraciliary effusion. Although the ocular finding resembles primary angle-closure glaucoma, bilateral infliction should always raise the suspicion that it is drug-induced glaucoma.
CASE REPORT: The authors present a case of a 51-year-old patient on Topamax therapy with sudden vertigo, headache and blurred vision. Ophthalmic examination revealed bilateral angle-closure glaucoma, which was initially treated in the classical manner by administration of local antiglaucoma drugs and pilocarpine, followed by administration of osmotically active substances and laser iridotomy. Only the subsequent discontinuation of Topamax and the use of local cycloplegics and corticosteroids led to the release of the anterior segment angle closure and normalization of intraocular pressure.
CONCLUSION: The indicating physician and ophthalmologist must be aware of the possible side effects of Topamax therapy to determine the correct diagnosis and to administer treatment appropriately.
PMID:35760585 | DOI:10.31348/2022/16
The continuum of care of anticancer treatment-induced hypothyroidism in patients with solid non thyroid tumors: time for an intimate collaboration between oncologists and endocrinologists
Expert Rev Clin Pharmacol. 2022 Jun 27. doi: 10.1080/17512433.2022.2093714. Online ahead of print.
ABSTRACT
INTRODUCTION: Hypothyroidism is a common adverse event of various anticancer treatment modalities, constituting a notable paradigm of the integration of the endocrine perspective into precision oncology.
AREAS COVERED: The present narrative review provides a comprehensive and updated overview of anticancer treatment-induced hypothyroidism in patients with solid non-thyroid tumors. A study search was conducted on the following electronic databases: PubMed, Google Scholar, Scopus.com, ClinicalTrials.gov, and European Union Clinical Trials Register from 2011 until August 2021.
EXPERT OPINION: In patients with solid non-thyroid tumors, hypothyroidism is a common adverse event of radiotherapy, high dose interleukin 2 (HD IL-2), interferon alpha (IFN-α), bexarotene, immune checkpoint inhibitors (ICPi), and tyrosine kinase inhibitors (TKIs), while chemotherapy may induce hypothyroidism more often than initially considered. The path forward for the management of anticancer treatment-induced hypothyroidism in patients with solid non-thyroid tumors is an integrated approach grounded on 5 pillars: prevention, vigilance, diagnosis, treatment and monitoring. Current challenges concerning anticancer treatment-induced hypothyroidism await counteraction, namely awareness of the growing list of related anticancer treatments, identification of predictive factors, counteraction of diagnostic pitfalls, tuning of thyroid hormone replacement, and elucidation of its prognostic significance. Close collaboration of oncologists with endocrinologists will provide optimal patient care.
PMID:35757870 | DOI:10.1080/17512433.2022.2093714
Comparison of Lamotrigine and Oxcarbazepine Monotherapy Among Chinese Adult Patients With Newly-Diagnosed Focal-Onset Epilepsy: A Prospective Observational Study
Front Neurol. 2022 Jun 10;13:855498. doi: 10.3389/fneur.2022.855498. eCollection 2022.
ABSTRACT
OBJECTIVE: We performed a prospective cohort study to compare the efficacy, safety, effect on mood, and quality of life between lamotrigine (LTG) and oxcarbazepine (OXC) monotherapy among Chinese adult patients with newly-diagnosed focal-onset epilepsy (FOE) with or without secondarily generalized tonic-clonic seizures.
METHODS: We enrolled 106 adult patients with new-onset FOE, of whom 56 were in the OXC group and 50 in the LTG group. Their clinical characteristics were detailly recorded especially basic seizure frequency, seizure types, and drug-related adverse events. Efficacy was evaluated as seizure-free (no seizure for 6 months), effective (seizure reduction by more than 50%), and ineffective (seizure reduction by less than 50%). Both intention-to-treat and per-protocol analyses were performed. We also assessed their mood state with the Zung Self-rating Scale for anxiety (Z-SAS) and Zung Self-rating Scale for Depression (Z-SDS) and quality of life (QOL) with Quality of Life in Epilepsy (QOLIE-31) at their baseline visit, 3-month visits, and 6-month visit. Intra-group comparisons in each group and inter-group comparisons between the two groups were made. Correlation analysis and multiple regression analysis were also conducted.
RESULTS: Except for gender, the two groups were well matched in any other characteristics such as primary seizure frequency and seizure types. In terms of efficacy, 33 patients in the OXC group were evaluated as seizure-free and 15 as effective, while in the LTG group, 31 were seizure-free, and nine were effective. No significant differences could be observed in efficacy between the two groups (P = 0.429). Through multiple logistic regression analysis, we found that OXC monotherapy was more likely to predict a seizure-free state (OR = 1.76) than LTG, but the difference didn't reach statistical significance (P = 0.322) after correcting for other clinical variables. Both groups had adverse events such as fatigue, drowsiness, dizziness, rash, and gastrointestinal discomfort, most of which were mild and transient. In the OXC group, the scores of SAS (P = 0.067) and SDS (P = 0.004) reduced at the 6-month visit, while the score of QOLIE-31 significantly increased (P = 0.001). In the LTG group, a significant decrease in SAS and SDS scores and an increase in QOLIE-31 scores could be witnessed (All P < 0.001). The inter-group comparison showed that improvement of SAS and SDS in the LTG group was more evident than that in the OXC group, which was of statistical significance. Correlational analysis indicated that the improvement of mood and life quality scales in both groups was independent of baseline seizure frequency and treatment efficacy. Multiple linear regression analysis indicated that LTG monotherapy was the only independent factor that could predict a better SAS (P = 0.01) and SDS (P = 0.019) outcome.
CONCLUSIONS: OXC and LTG are effective as monotherapy and can be considered first-line selection among adult patients with new-onset FOE. Most adverse events are mild, transient, and tolerable. The two drugs improve the mood state of patients, though LTG is superior to OXC in this respect. OXC and LTG have great power in enhancing patients' quality of life. The positive effect on the psychosocial well-being of epilepsy patients may be one of the intrinsic pharmacological properties of LTG and OXC.
PMID:35756921 | PMC:PMC9226306 | DOI:10.3389/fneur.2022.855498
Pharmacists Can Do More to Reduce Harm From Adverse Drug Reactions
Sr Care Pharm. 2022 Jul 1;37(7):245-246. doi: 10.4140/TCP.n.2022.245.
NO ABSTRACT
PMID:35752924 | DOI:10.4140/TCP.n.2022.245
Senior Care Pharmacists Must Be the Disruptive Force that Reduces Adverse Drug Events in Older People
Sr Care Pharm. 2022 Jul 1;37(7):247-249. doi: 10.4140/TCP.n.2022.247.
NO ABSTRACT
PMID:35752921 | DOI:10.4140/TCP.n.2022.247